MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: EXPERT TIBIAL NAIL; ROD, FIXATION, INTRAMEDULLARY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown constructs: expert tibial nail/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in italy as follows: this report is being filed after the review of the following journal article: greco t., et al (2021) uncoated vs.Antibiotic-coated tibia nail in open diaphyseal tibial fracture (42 according to ao classification): a single center experience, hindawi biomed research international volume xxxx, pages 1-9 (italy).This retrospective, the nonrandomized study aims to analyze the use of antibiotic-coated nails in a specific type of open tibia fracture (the 42 according to the ao classification) comparing the results obtained with the standard and the antibiotic coated nails in terms of bone and soft tissue healing rate, infection rate, reoperation rate, difference in time between trauma and nailing (ttn), and hospital stay.From january 2016 to december 2018 all patients with open tibia fractures who accessed the emergency room were collected.After selecting the patients they are divided into 2 groups: those treated with a standard tibia intramedullary nail (etnexpert tibial nail, depuy synthes) and those with a gentamicin-coated intramedullary tibia nail (etn protect, depuy synthes).Of the patients included in the study were 46, 23 treated with standard intramedullary tibia nailing (expert tibia nail, synthes), and 23 underwent surgical treatment with etn protect.The mean age in the group of patients treated with etn nails was 41.09 (ds 17.56), with 19 males and 4 females.In the group of patients treated with the etn protect nail, the average age was 45.81 (sd 19.13), with 18 males and 5 females.The minimum follow-up period was 18 months to a maximum of 30 months.Reported complications: etn group: patient no.2, an 82-year-old male, had a superficial surgical site infection.Which was treated with surgical wound debridement and targeted antibiotics based on intraoperative microbiological swab results.Patient no.3, a 23-year-old male, had delayed consolidation which required dynamization.Patient no.6, a 21-year-old male, had osteomyelitis and infected nonunion.Underwent surgical wound debridement and targeted antibiotics based on intraoperative microbiological swab results.This patient had a revision of infected nonunion according to the masquelet technique.Patient no.7, a 20-year-old male, had delayed consolidation which required dynamization.Patient no.8, a 32-year-old female, had a superficial surgical site infection which was treated with surgical wound debridement and targeted antibiotics based on intraoperative microbiological swab results.Patient no.9, a 55-year-old female, had a superficial surgical site infection, which was treated with surgical wound debridement and targeted antibiotics based on intraoperative microbiological swab results, and delayed consolidation.Required dynamization for delayed healing.Patient no.12, a 19-year-old male, had delayed union which required dynamization.Patient no.13, a 54-year-old male, had delayed union which required dynamization.Patient no.15, a 29-year-old female, had delayed union which required dynamization.Etn protect group: patient no.3, a 58-year-old male, had delayed consolidation.Required dynamization.Patient no.8, a 63-year-old male, had delayed consolidation.Required dynamization.Patient no.10, a 30-year-old male, had delayed consolidation.Required dynamization.Patient no.15, a 57-year-old male, had a superficial surgical site infection.Required a second intervention for wound debridement and subsequent targeted antibiotic therapy.Patient no.16, a 22-year-old male, had a superficial surgical site infection, which required a second intervention for wound debridement and subsequent targeted antibiotic therapy, and delayed consolidation which required dynamization.Patient no.17, a 62-year-old male, had a superficial surgical site infection which required a second intervention for wound debridement and subsequent targeted antibiotic therapy.Patient no.19 45-year-old female, had delayed consolidation.Required with dynamization.2 patients had nonunion.This report is for unknown synthes etnexpert tibial nail and unknown synthes etnexpert tibial nail protect.This is report 4 of 17 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: EXPERT TIBIAL NAIL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15372845
• MDR Text Key: 299451673
• Report Number: 8030965-2022-06494
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention